If the movie The Graduate were rebooted today, this would undoubtedly be the advice that Mr. McGuire would give the young Benjamin. However, a lot of legal and regulatory questions still swirl around the future of cannabidiol (CBD) oil products. At the GMA Conference earlier this week, Sharon Mayl, senior advisor for policy at the Food and Drug Administration (FDA) – and one of the individuals tasked with overseeing the FDA’s efforts with regard to marijuana and related products – gave an assessment of where things currently stand with regard to CBD.
Mayl noted that the issues regarding CBD products can be complex and confusing and that currently there is an interagency team at the FDA meeting regularly on marijuana issues. She acknowledged that the December 2018 Farm Bill eased legal impediments to the marketing of hemp-related products but nothing in the bill removed these products from FDA authority or oversight, so any type of therapeutic benefit claim associated with CBD oil would be considered a drug claim by FDA.
Pursuant to the idea that the FDA retains authority over CBD oil products, Mayl noted that because a CBD oil product was recently approved for treatment of certain types of seizures, CBD oil, an approved drug, cannot be used in foods or dietary supplements. She noted that there is an exception if the ingredient had been marketed in foods or dietary supplements prior to its approval as a drug but that the FDA has seen no evidence this exception applies to CBD oil. The FDA, she observed, can also create an exception through notice and comment rulemaking. (Now-departing Chairman Scott Gottlieb had previously indicated that the FDA may look for a path forward for the use of CBD oil in foods and supplements.)
With respect to cosmetic and other topical products with CBD oil, the same prohibitions do not apply. However, Mayl said such products must still be safe and not misbranded, and cosmetics can run afoul of FDA requirements if they make drug claims.
Finally, Mayl touched briefly on enforcement. She cautioned companies that when the FDA has had CBD oil products tested in the lab, they have found instances where the actual CBD oil content did not match product claims. She noted that one of the challenges in this space is the lack of data on safety and efficacy and that the FDA will continue to take action against violative products. However, like any government agency, the FDA has finite resources, and she closed by stating that the FDA will prioritize enforcement to focus on claims that threaten or impact public health.
On a side note, now that the 2018 Farm Bill has legalized at least certain types of CBD oil products, don’t be surprised if the Federal Trade Commission, which shares jurisdiction over such products with the FDA, also begins looking more closely at the types of claims that are out in the marketplace. Companies wanting to capitalize on the CBD oil gold rush would be wise to do so cautiously and with an eye toward potential federal and state regulatory risks.